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The OnFlex™ Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, such as in the repair of inguinal hernias.

The OnFlex™ Mesh is a self-expanding, non-absorbable, sterile device made from monofilament polypropylene mesh and has a lightweight large pore design. This construction allows a prompt fibroblastic response through the interstices of the mesh as observed in a preclinical model, which may not correlate to performance in humans. The OnFlex™ Mesh has an anatomical shape design to cover potential defect areas. The OnFlex™ Mesh also contains a pocket on the larger medial apex of the mesh to facilitate insertion and positioning of the device.

The OnFlex™ Mesh contains SorbaFlex™ Memory Technology comprised of an absorbable PDO monofilament which forms an interrupted ring. SorbaFlex™ Memory Technology provides memory and stability to the device, facilitating ease of initial insertion and proper placement of the device. The PDO monofilament is folded and welded onto itself at the ends. The PDO monofilament fully degrades by means of hydrolysis in vivo in 6 – 8 months. The PDO monofilament is dyed violet by adding D & C Violet No. 2. The interrupted ring is placed within a mesh tube constructed from a knitted polypropylene monofilament. The purpose of the mesh tube is to contain the interrupted recoil ring during the degradation process. The interrupted ring, contained in the mesh tube, is sewn between two layers of mesh with polytetrafluoroethylene (PTFE) monofilament.

The OnFlex™ Mesh has a blue limit line at the lateral portion of the mesh, composed of polypropylene monofilament dyed with Phthalocyaninato(2-) copper colorant, to provide visual feedback for where the device can be tailored. The OnFlex™ Mesh can be tailored at the opening of the interrupted ring or outside of the blue limit line.

The OnFlex™ Mesh is offered in two sizes: medium (0115410) and large (0115411). The OnFlex™ Mesh is considered a tissue contacting permanent implant.

The provided FDA 510(k) clearance letter for the OnFlex™ Mesh (K251955) indicates that this is a Special 510(k) submitted to notify the FDA of changes to the device labeling only. The device itself remains identical to its predicate, OnFlex™ Mesh (K142711), cleared in 2015.

Therefore, the submission explicitly states: "No non-clinical or clinical testing was provided in support of this Special 510(k)."

This means that the document does not contain any information regarding acceptance criteria or a study proving that the device meets those criteria, as no new testing was performed for this specific submission. The substantial equivalence is based on the device's identity to its predicate and the conclusion that the labeling changes do not affect safety or effectiveness.

Because no new studies were conducted or presented in this document for the K251955 submission, I cannot provide the requested information. The document focuses solely on demonstrating that the labeling updates do not alter the substantial equivalence to the original predicate device (K142711).

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